Does it include CAPA guidance?

Yes, it integrates finding severity with CAPA depth requirements, requiring full root cause analysis for Major findings and providing verification timelines.

How does the audit schedule optimizer work?

It uses a Python-based tool to analyze process risk levels, previous findings, and audit history to generate a prioritized, risk-based schedule in JSON or interactive formats.

How are nonconformities classified within the skill?

The skill utilizes a standardized decision tree to categorize findings as Major, Minor, or Observations based on systematic failure, recurrence, and potential impact on product safety.

What standard does this skill support?

This skill specifically supports ISO 13485:2016, the international standard for medical device quality management systems, covering internal audit requirements.

Can this help with external regulatory audits?

Yes, it includes specialized workflows for external audit preparation, including readiness checklists, personnel briefing protocols, and mock audit procedures.

QMS Audit Expert (Medical Devices)

Name: QMS Audit Expert (Medical Devices)
Author: borghei

byborghei

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Security & Testing

Guides and automates ISO 13485 internal audits for medical device quality management systems, from risk-based planning to CAPA verification.

The QMS Audit Expert skill provides a comprehensive methodology for managing ISO 13485 internal audits within medical device environments. It enables users to create risk-based audit schedules, execute systematic audits with clause-specific question sets, classify nonconformities (Major/Minor/Observation), and prepare for external regulatory inspections. By integrating specialized tools for schedule optimization and providing standardized documentation templates for findings and evidence collection, it ensures a robust, compliant, and audit-ready Quality Management System (QMS) that meets strict regulatory requirements.

Key Features

01Standardized nonconformity classification using logic-based decision trees

02Comprehensive external audit readiness protocols and mock audit checklists

03Clause-specific audit checklists and evidence collection guides for ISO 13485

0450 GitHub stars

05Risk-based internal audit program planning and automated scheduling

06CAPA (Corrective and Preventive Action) integration and effectiveness tracking

Use Cases

01Developing an annual risk-based audit schedule that prioritizes high-risk QMS processes

02Preparing for certification body or regulatory audits through rigorous mock inspections

03Conducting systematic internal audits and documenting findings with objective evidence

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add borghei/claude-skills qms-audit-expert

For use in Claude.ai and ChatGPT

Download Skill